5-azacytidine for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndromes+2 More
5-azacytidine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well 5-azacitidine and decitabine work when given together in treating patients with myelodysplastic syndrome.

Eligible Conditions
  • Myelodysplastic Syndromes
  • Nerve Crossover

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment

Year 2
Enzyme expression important in DEC metabolism: DCK, UCK2, and CDA by QRT-PCR.
Surface expression of markers of monocytic and granulocytic differentiation by flow cytometry: CD11b, CD14 and CD15
Year 2
Correlation of clinical response IWG criteria with disease biological phenotype
Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by flow cytometry
Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by quantitative immunofluorescence
Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by standard pathologic interpretation of IHC
Duration of response (DOR)
Month 6
Cumulative incidence of response for both CR and overall response
Overall response rate (ORR) of 5AZA-alt-DEC
Day 30
Safety evaluation by tabulation of all AEs and SAEs per CTACE version 5.0

Trial Safety

Trial Design

1 Treatment Group

5AZA-alt-DEC
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: 5-azacytidine · No Placebo Group · Phase < 1

5AZA-alt-DECExperimental Group · 2 Interventions: 5-azacytidine, Decitabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Decitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment

Who is running the clinical trial?

Benjamin TomlinsonLead Sponsor
2 Previous Clinical Trials
67 Total Patients Enrolled
Benjamin H Tomlinson, TomlinsonPrincipal InvestigatorCleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have performance status of 60% or greater by Karnofsky Performance Status (KPS).
You have a diagnosis of anemia or thrombocytopenia with a platelet count of <100 x 109/L or transfusion dependence for red-cells or platelets or absolute neutrophil count < 1.
You have a lower risk MDS and must have failed or have contraindications to available therapies (e.g.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.